Calendar

pharmadog

Week of Dec 1, 2025

Dec 2, 2025approval256d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 2, 2025approval256d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

Dec 2, 2025approval256d agoOLANZAPINE — FDA approvalTorrent Pharma Inc

Sponsor: TORRENT PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 2, 2025approval256d agoJAYPIRCA (PIRTOBRUTINIB) — FDA approvalEli Lilly and Co

Sponsor: LOXO ONCOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 2, 2025approval256d agoPROPOFOL — FDA approvalBika Biotechnology Guanzhou Co Ltd

Sponsor: NANJING KING FRIEND. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 2, 2025approval256d agoLEVETIRACETAM — FDA approvalLEVETIRACETAM

Sponsor: KNACK. Form: INJECTABLE. Route: INTRAVENOUS

full page →LEVETIRACETAM →fda approvals ↗

Dec 2, 2025approval256d agoSITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — FDA approvalmetformin hydrochloride ER

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →metformin hydrochloride ER →fda approvals ↗

Dec 2, 2025device 510k256d agoBecton, Dickinson and Company — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe (510k cleared)BECTON DICKINSON & CO

Product code: NGT. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Dec 2, 2025device 510k256d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Dec 2, 2025device 510k256d agoChangzhou New Med Micro-Medtech Co., Ltd. — Disposable Endoscopic Injection Needles (510k cleared)

Product code: FBK. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Dec 2, 2025device 510k256d agoAura Wellness, LLC — Aura Wave (510k cleared)

Product code: SGT. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Dec 2, 2025device 510k256d agoMighty Oak Medical — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Dec 2, 2025device pma256d agoMedtronic, Inc. — Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P — Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K — Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L — Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 2, 2025device recall256d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025approval255d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →ERTUGLIFLOZIN →fda approvals ↗

Dec 3, 2025approval255d agoMACITENTAN — FDA approvalJOHNSON & JOHNSON

Sponsor: SEASONS BIOTECH. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 3, 2025approval255d agoMACITENTAN — FDA approvalMACITENTAN

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →MACITENTAN →fda approvals ↗

Dec 3, 2025approval255d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoFresenius Kabi USA, LLC recall (Cls I)Fresenius Kabi USA LLC

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale). — Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

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Week of Dec 1, 2025